Sphincter treatment apparatus
View Patent ↗A sphincter treatment apparatus includes an energy delivery device introduction member including a proximal end with a first radius of curvature and a distal end with a second radius of curvature. The introduction member is configured to be introduced into the sphincter in a non-deployed state and to be expanded to a deployed state to at least partially expand the sphincter or an adjoining structure. An energy delivery device is coupled to the introduction member. A retainer member is coupled to the energy delivery device introduction member and configured to controllably position the introduction member in an orifice of the sphincter.
1. A method of treating tissue regions at or near the lower esophageal sphincter comprising
providing an expandable structure carrying an energy delivery device comprising at least one tissue-piercing needle electrode sized and configured for deployment between a retracted position and an extended position, the structure having a non-deployed state and a deployed state,
introducing the structure while in the non-deployed state and with the at least one tissue-piercing needle electrode in the retracted position through an esophagus to a first tissue region comprising the cardia of the stomach,
expanding the structure to the deployed state in the first tissue region,
deploying the at least one tissue-piercing needle electrode to the extended position to pierce sub-mucosal tissue in the first tissue region,
delivering sufficient radio frequency energy from the at least one needle-piercing electrode to cause necrosis of the sub-mucosal tissue due to resistance heating to create a sub-mucosal lesion in the interior of the first tissue region,
moving the at least one tissue-piercing electrode to the retracted position,
collapsing the structure to the non-deployed state,
moving the structure while in the non-deployed state and with the at least one tissue-piercing needle electrode in the retracted position from the first tissue region to a second tissue region comprising the lower esophageal sphincter,
expanding the structure to the deployed state in the second tissue region,
deploying the at least one tissue-piercing needle electrode to the extended position to pierce sub-mucosal tissue in the second tissue region,
delivering sufficient radio frequency energy from the at least one needle-piercing electrode to cause necrosis of the sub-mucosal tissue due to resistance heating to create a sub-mucosal lesion in the interior of the second tissue region,
collapsing the structure to the non-deployed state,
moving the at least one tissue-piercing electrode to the retracted position, and
removing the structure from the esophagus, whereby a pattern of sub-mucosal lesions is formed in the first and second tissue regions to create a desired tissue effect.
2. A method according to claim 1
wherein the desired tissue effect includes a reduction in a duration of lower esophageal sphincter relaxation.
3. A method according to claim 1
wherein the desired tissue effect includes a reduction in a frequency of reflux of stomach contents into the esophagus.
4. A method according to claim 1
wherein the desired tissue effect includes a reduction of a frequency of a symptom of reflux of stomach contents into the esophagus.
5. A method according to of claim 1
wherein the desired tissue effect includes a reduction of an incidence of a sequela of reflux of stomach contents into the esophagus.
6. A method according to claim 1
wherein the desired tissue effect includes a tightening of the lower esophageal sphincter.
7. A method according to claim 1 , further comprising
introducing a fluid to at least one of the first and second tissue regions.
8. A method according to claim 1
wherein the desired tissue effect includes blocking of an electrical conduction pathway in at least one of the esophagus, the lower esophageal sphincter, and the cardia.
9. A method according to claim 1
wherein the desired tissue effect includes ablating an electrical pathway in at least one of the esophagus, the lower esophageal sphincter, and the cardia.
10. A method according to claim 1
wherein the desired tissue effect includes ablating an electrical foci in at least one of the esophagus, the lower esophageal sphincter, and the cardia.
11. A method according to claim 1
wherein the desired tissue effect includes inducing necrosis of an electrical conduction pathway in at least one of the esophagus, the lower esophageal sphincter, and the cardia.
12. A method according to claim 1
wherein the expandable structure is a basket assembly comprising a first arm, a second arm, and a third arm coupled together.